Leap Therapeutics Announces Pricing of $11.5 Million Public Offering of Common Stock and Warrants

On February 1, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the pricing of an underwritten public offering of 6,571,428 shares of its common stock and warrants to purchase up to 6,571,428 shares of its common stock (Press release, Leap Therapeutics, FEB 1, 2019, View Source [SID1234533017]). Each share of common stock is being sold together with a warrant to purchase one share of common stock for a combined offering price of $1.75 per share and accompanying warrant. The warrants will be exercisable commencing on the date of issuance, will expire seven years from the date of issuance, and have an exercise price of $1.95 per share, subject to certain adjustments. The gross proceeds to Leap from this offering are expected to be approximately $11.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Leap and excluding the proceeds from the exercise of any warrants. All shares of common stock and warrants to purchase common stock to be sold in the offering are being sold by Leap. The shares of common stock and warrants are being purchased together but will be issued separately and will be immediately separable upon issuance. In addition, Leap has granted to the underwriters a 30-day option to purchase up to an aggregate of an additional 985,714 shares of its common stock offered in the public offering and/or warrants to purchase up to 985,714 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on February 5, 2019, subject to satisfaction of customary closing conditions.

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Raymond James & Associates, Inc. and Ladenburg Thalmann are acting as book-running managers for the offering.

Leap intends to use the net proceeds from the offering for general corporate purposes, which may include, without limitation, funding new clinical trials of DKN-01 and TRX518 and the continuation of ongoing studies, capital expenditures, working capital and general and administrative expenses.

The shares are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A preliminary prospectus supplement and the related prospectus have been filed with the SEC and a final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC. The preliminary prospectus supplement and accompanying prospectus is also available, and the final prospectus supplement and accompanying prospectus will be available, for free on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected]; or from Ladenburg Thalmann, 277 Park Ave, 26th Floor, New York, NY 10172, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

I-Mab Biopharma and Bio-Cancer Treatment International Announce Intention for Collaboration on Arginine Depletion Therapy and Biomarker Study, with Plans for I-Mab to Establish a Translational Medicine Lab in Hong Kong

On February 1, 2019 I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, reported that it has entered into a memorandum of understanding (MOU) with Hong Kong-based Bio-Cancer Treatment International Limited (BCT) to jointly explore and investigate new therapeutic potentials for BCT’s arginine depletion therapy in autoimmune diseases and cancers (Press release, I-Mab Biopharma, FEB 1, 2019, View Source [SID1234533019]).

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I-Mab Biopharma and Bio-Cancer Treatment International Announce Intention for Collaboration on Arginine Depletion Therapy and Biomarker Study, with Plans for I-Mab to Establish a Translational Medicine Lab in Hong Kong
I-Mab Biopharma and Bio-Cancer Treatment International Announce Intention for Collaboration on Arginine Depletion Therapy and Biomarker Study, with Plans for I-Mab to Establish a Translational Medicine Lab in Hong Kong
Under the terms of the MOU, I-Mab and BCT will work together to explore the potential of arginine depletion therapy in autoimmune diseases, as well as biomarkers in arginine and other immunologic targets in the tumor microenvironment for experimental cancer immunotherapy.

In conjunction with this development collaboration, I-Mab also plans to establish a translational medicine lab in Hong Kong to conduct exploratory biomarker work on BCT’s lead drug candidate, BCT-100, as well as a number of important assets in I-Mab’s own pipeline. Over the longer term, I-Mab will consider expanding the lab into a full-functioning R&D center in Hong Kong, taking advantage of the local scientific talent pool, clinical resources and government initiatives to encourage life sciences development.

"BCT is a biotech company with an established unique focus on targeting arginine metabolism to treat cancers and immune disorders. We are especially impressed by BCT’s ability to bring about collaborations among like-minded academic groups and clinician-scientists, to really understand, exploit and expand the therapeutic potential of something as vital as amino acid metabolism. We look forward to working closely with BCT to explore creating synergy with our pipelines. The partnership also provides I-Mab with an opportunity to set up a world-class translational medicine hub in Hong Kong, with further potential to develop clinical presence in Hong Kong," said Jielun Zhu, Chief Financial Officer of I-Mab.

"BCT is extremely honored to be working with I-Mab’s team of highly experienced biotech professionals in developing first-in-class biologics in autoimmune diseases and cancers to find ways to collaborate. The proposed biomarker study is very important to BCT both as precision medicine to identify cancer patients that would benefit the most from the BCT-100 treatment and also to apply the arginine depletion therapy to a wider patient population," said Derek Wong, CFO of BCT.

CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer

On February 1, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, FEB 1, 2019, View Source [SID1234533003]). In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. Based on the positive CHMP recommendation, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future.

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The CHMP recommendation is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin, paclitaxel and carboplatin helped people live significantly longer, compared with Avastin and chemotherapy (median overall survival [OS]=19.8 versus 14.9 months; hazard ratio [HR]=0.76; 95%, CI: 0.63–0.93; p=0.006) in the intention-to-treat (ITT) population.[1] The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

"We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based combination, which represents a significant step towards bringing a new treatment option to people across Europe with advanced, non-squamous non-small cell lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The IMpower150 study, on which this opinion is based, demonstrated an overall survival benefit, including those in key populations such as people with EGFR- or ALK-positive mutations or liver metastases."

About the IMpower150 study
IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. A total of 1,202 people were enrolled and randomised (1:1:1) to receive:

Tecentriq plus carboplatin and paclitaxel (Arm A), or
Tecentriq and Avastin plus carboplatin and paclitaxel (Arm B), or
Avastin plus carboplatin and paclitaxel (Arm C, control arm).
The co-primary endpoints comparing Arms B and C were OS and progression-free survival (PFS), as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) and assessed in the ITT-WT subpopulation. Key secondary endpoints included investigator-assessed PFS, OS and safety in the ITT population.

A summary of the ITT data from the IMpower150 study that support this recommendation is included below:[1]

Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer, compared with Avastin and chemotherapy (median OS=19.8 versus 14.9 months; HR=0.76; 95% CI: 0.63–0.93; p=0.006).
In addition, Tecentriq in combination with Avastin and chemotherapy reduced the risk of disease worsening or death (PFS) by 41% compared with Avastin and chemotherapy (HR=0.59; 95% CI: 0.50–0.69, p<0.0001).
Tecentriq in combination with Avastin and chemotherapy shrank tumours (overall response rate [ORR]) in 56.4% of people (95% CI: 51.4–61.4) compared with 40.2% of people (95% CI: 35.3–45.2) on Avastin and chemotherapy.
2.8% of people receiving Tecentriq in combination with Avastin and chemotherapy experienced a complete response (CR), and 53.7% of people experienced a partial response (PR).
The median duration of response (DoR) for people receiving Tecentriq in combination with Avastin and chemotherapy was 11.5 months (95%, CI: 8.9–15.7) compared with 6.0 months (95% CI: 5.5–6.9) for people on Avastin and chemotherapy.
The most common adverse reactions (≥20%) in people receiving Tecentriq in combination with Avastin and chemotherapy were fatigue and lack of energy (asthenia; 50%), hair loss (alopecia; 48%), nausea (39%), diarrhoea (32%), constipation (30%), decreased appetite (29%), joint pain (arthralgia; 26%), hypertension (25%), and pain from nerve damage (peripheral neuropathy; 24%).
About NSCLC
Lung cancer is the leading cause of cancer death globally.[2] Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[3] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.[3]

About the Tecentriq (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T cell tumour infiltration and enabling priming and activation of T cell responses against tumour antigens.

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has nine Phase III lung cancer studies underway, evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq in combination with Avastin and chemotherapy was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.

About Avastin (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

Bausch Health Companies Announces Participation In Upcoming Investor Conferences

On February 1, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the Company will participate in two investor conferences in February and March (Press release, Valeant, FEB 1, 2019, View Source [SID1234533020]).

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Paul S. Herendeen, executive vice president and chief financial officer, and William Woodfield, vice president and treasurer, are scheduled to participate at the J.P. Morgan Global High Yield & Leveraged Finance Conference in Miami, Fla. on Feb. 25, 2019 at 11:40 a.m. EST.

Joseph C. Papa, chairman and chief executive officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Barclays Global Healthcare Conference 2019 in Miami, Fla. on March 13, 2019 at 10:45 a.m. EDT.

A live webcast and audio archive of the Barclays event will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

Iovance Biotherapeutics to Present at Upcoming Investor and Medical Conferences

On February 1, 2019, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will participate and present at the following upcoming conferences (Press release, Iovance Biotherapeutics, FEB 1, 2019, View Source;p=RssLanding&cat=news&id=2385716 [SID1234533021]):

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5th Annual Immuno-Oncology 360° conference in New York, February 6-8, 2019
Presenter: Maria Fardis, Ph.D., President and Chief Executive Officer
Session: Next Generation Cell Therapy Plenary
Title: Advancing the Development of Tumor Infiltrating Lymphocytes for Solid Tumors
Location: Crowne Plaza Times Square
Date/Time: February 8 at 11:10 a.m. EST

Guggenheim Healthcare Talks Idea Forum Oncology Day in New York on February 14, 2019
Date/Time: Thursday, February 14, 2019 at 3:00 p.m. EST
Location: The St. Regis New York Hotel
Webcast: A live and archived audio webcast of the presentation will be available in the Investors section at www.iovance.com.

ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco, February 28-March 2, 2019
Presenter: Amod Sarnaik, M.D. – H. Lee Moffitt Cancer Center
Poster Presentation Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients previously treated with at least one prior systemic therapy
Abstract Number: 136
Date/Time: The poster will be presented on Friday, March 1, 2019 from 11:30 a.m.-1:00 p.m. and 5:30 p.m.-6:30 p.m. PST (Poster Session B, Board F1)
Location: San Francisco Marriott Marquis